T2 Biosystems Announces New Data at ASM Microbe 2016 Demonstrating Benefits of Adopting T2Candida® Panel for Diagnosing Sepsis in Clinical Settings

LEXINGTON, Mass., June 21, 2016 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced the T2Candida® Panel was the focus of one slide session and three poster presentations during ASM Microbe 2016, integrating the American Society of Microbiology’s two premier events, the General Meeting and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The annual meeting took place June 16-20 in Boston. Data from these third-party studies demonstrate the T2Candida Panel’s ability to quickly and accurately diagnose sepsis and strengthen the growing body of evidence supporting the integration of rapid diagnostic testing in hospitals and clinical settings where patients are demonstrating possible symptoms of the disease, one of the leading causes of death in the U.S. and the most expensive hospital-treated condition.

“The data presented at ASM Microbe 2016 provide further confirmation that the T2Candida Panel is superior in its ability to rapidly and accurately detect sepsis,” said John McDonough, president and CEO of T2 Biosystems. “Every minute counts when patients are faced with an illness like sepsis. These case studies support our belief that use of rapid diagnostics direct from whole blood – important and potentially life-saving technologies – should be adopted in hospitals across the country. It is gratifying to see the early adopters of the technology so anxious to share not only the clinical success of the T2Candida Panel, but also the early trends in cost savings provided by less traumatic illness and steep decreases in the administration of unnecessary medications.”

“When I first entered healthcare, I wasn’t aware the extent to which Candida infections were a problem, including the costs associated with inappropriate antifungal therapies and sadly, patient deaths due to slower diagnosis times. The ability to now diagnose and start treating these infections in three to five hours has made a significant impact on our patient care,” said Sandy J. Estrada, an infectious diseases clinical pharmacist for Lee Memorial Health System. “Since implementing the T2Candida Panel, we’ve been able to reduce hospital stays, decrease costs for the hospital and most importantly, diagnose and treat patients faster so they can go home sooner.”

Data Highlights

Slide Presentation: “Early Experience with T2Candida and Antifungal Utilization at a Large Community Health System,” was presented by researchers from Lee Memorial Health System, the fourth largest healthcare system in the U.S. with 1,423 beds. Key findings on the 182-patient study included the following:

  • T2Candida reduced time to appropriate antifungal therapy by 34 hours (previously, time to appropriate therapy averaged 40 hours; with the T2Candida Panel, investigators reported an average of six hours)
  • Unnecessary antifungal therapy was avoided in 41 percent of patients
    • Unnecessary antifungal therapy was discontinued after one dose in 15 percent of patients
  • Earlier discontinuation of unnecessary antifungal therapies suggested increased cost savings for hospitals 

Poster Presentation: “Performance Evaluation of the T2Candida Panel in the ICU Setting - Data from an Ongoing Study,” presented by investigators from Statens Serum Institut, showed the T2Candida Panel performed superior to blood culture and Candida Mannan antigen (MAg) testing in two large hospital settings. Key findings included the following:

  • Increase in sensitivity from 54.5 to 90 percent when comparing blood culture to the T2Candida Panel
  • Combined, the T2Candida Panel and Candida MAg using a stringent cut-off achieved 100 percent test sensitivity with discreet reduction of specificity
  • Adopting the T2Candida Panel for high-risk patients may improve diagnosis due to increased sensitivity and speed

Poster Presentation: “Evaluation of BacT/Alert FA Blood Culture Bottles and T2Candida Assay for Detection of Candida in the Presence of Antifungals,” presented by investigators from the University of Houston College of Pharmacy, suggests that T2Candida Panel performance is not impacted by antifungals and can be a reliable method for detecting patients with candidemia. Key findings include the following:

  • The presence of antifungals fluconazole (FLU) and caspofungin (CAS) did not impact the performance of the T2Candida Panel
  • FLU reduced the detection rate of Candida in blood culture bottles, and both FLU and CAS prolonged time to positivity in blood culture bottles (34.6 ± 16.3 hrs versus 5.3 ± 0.8 hrs for the T2Candida Panel)

Poster Presentation: “Verification of T2Candida Panel for the Identification of Candida Species in EDTA-Preserved Whole Blood,” presented by investigators at Geisinger Medical Laboratories, demonstrated that the T2Candida Panel showed high sensitivity and specificity when challenged with spiked blood samples. Key findings included the following:

  • The T2Candida Panel demonstrated analytical sensitivity of 100 percent and specificity of 98.7 percent in spiked blood samples
  • Prompt results indicating presence of Candida can contribute to improvement in treatment and possibly improve patient outcomes
  • Real clinical sample performance may be diminished by variables outside of protocol, including use of 6mL EDTA tubes instead of suggested 4mL tubes

About Candida
Candidemia is a systemic fungal infection that occurs when Candida organisms in the blood spread to organs and tissues throughout the body. Candidemia is the fourth- leading hospital-acquired bloodstream infection and the most lethal form of common bloodstream infection that causes sepsis, according to the Center for Disease Control (CDC), with an approximate 40 percent mortality rate. In the absence of a rapid, accurate diagnostic, appropriate therapeutic intervention for candidemia is often delayed, resulting in a mortality rate that is three to four times higher than when early, targeted therapy is initiated. According to a study published in Antimicrobial Agents and Chemotherapy, the mortality rate can be reduced to 11 percent with the initiation of targeted therapy within 12 hours of presentation of symptoms. On average, candidemic patients require 40 days of hospitalization and have a hospital cost of $130,000.

About Sepsis
Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year, according to the U.S. Department of Health and Human Services. The T2Candida Panel uses T2 Magnetic Resonance (T2MR®) technology to detect the presence of the five clinically relevant species of Candida, the most lethal form of common blood stream infections that cause sepsis, directly from a patient's blood sample in approximately three to five hours, enabling physicians to make timely treatment decisions to reduce adverse outcomes, patient mortality and costs.

About the T2Candida Panel
The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three to five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient's length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a Serious Threat.

About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company's diagnostic products and the ability to bring such products to market. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. For more information on risk factors for T2 Biosystems, Inc.’s business, please refer to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 9, 2016, under the heading “Risk Factors,” and other filings the Company makes with the Securities and Exchange Commission from time to time.  Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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